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Suppliers and packagers for generic pharmaceutical drug: CYCLOPENTOLATE HYDROCHLORIDE; PHENYLEPHRINE HYDROCHLORIDE
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CYCLOPENTOLATE HYDROCHLORIDE; PHENYLEPHRINE HYDROCHLORIDE
Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.
| Applicant | Tradename | Generic Name | Dosage | NDA | NDA/ANDA | Supplier | Package Code | Package | Marketing Start |
|---|---|---|---|---|---|---|---|---|---|
| Alcon Labs Inc | CYCLOMYDRIL | cyclopentolate hydrochloride; phenylephrine hydrochloride | SOLUTION/DROPS;OPHTHALMIC | 084300 | ANDA | Alcon Laboratories, Inc. | 0065-0359-02 | 2 mL in 1 BOTTLE, PLASTIC (0065-0359-02) | 1958-06-30 |
| Alcon Labs Inc | CYCLOMYDRIL | cyclopentolate hydrochloride; phenylephrine hydrochloride | SOLUTION/DROPS;OPHTHALMIC | 084300 | ANDA | Alcon Laboratories, Inc. | 0065-0359-05 | 5 mL in 1 BOTTLE, PLASTIC (0065-0359-05) | 1958-06-30 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >NDA/ANDA | >Supplier | >Package Code | >Package | >Marketing Start |
ppliers for the Pharmaceutical Drugs: Cyclopentolate Hydrochloride and Phenylephrine Hydrochloride
Introduction
The pharmaceutical landscape for cyclopentolate hydrochloride and phenylephrine hydrochloride is integral to ophthalmic and diagnostic medicine. Both active pharmaceutical ingredients (APIs) serve crucial roles: cyclopentolate as a mydriatic agent for pupil dilation during examinations, and phenylephrine for vasoconstriction and as a decongestant in ophthalmology and other treatments.
Securing reliable suppliers for these compounds involves understanding the global manufacturing footprint, quality standards, regulatory approvals, and supply chain stability. This report evaluates key suppliers, highlighting their market positions, manufacturing capabilities, and compliance standards.
Market Overview
Cyclopentolate Hydrochloride is commonly used as a mydriatic agent, with applications in ophthalmic diagnostics and preoperative procedures. Its manufacturing is often associated with specialized pharmaceutical chemical producers with deep expertise in chiral molecules, as the compound's stereochemistry influences efficacy.
Phenylephrine Hydrochloride acts primarily as a vasoconstrictor, frequently found in ophthalmic solutions, nasal sprays, and injectable forms. Its widespread use sustains a robust supply chain with high-volume manufacturing.
Both APIs are included on international pharmacopoeias like USP, EP, and JP, and require suppliers to adhere to strict GMP standards.
Key Suppliers for Cyclopentolate Hydrochloride
1. Shaanxi Fuheng (FH) Enterprise Group Co., Ltd.
Based in China, FH is a prominent producer of sterile and non-sterile APIs, including cyclopentolate hydrochloride. They demonstrate compliance with stringent GMP standards, regulatory approvals in multiple jurisdictions, and substantial export volumes. Their manufacturing facility is certified by the Chinese FDA and holds certifications aligned with global standards such as ISO 9001.
2. Jiangsu Hengrui Medicine Co., Ltd.
A leading Chinese pharmaceutical company with a portfolio of APIs, Hengrui supplies cyclopentolate hydrochloride with high purity levels. Their manufacturing adheres to international GMP guidelines, and they have established regulatory approvals in markets like Europe, the US, and Southeast Asia.
3. Jinan MgiPharma Co., Ltd.
Specialized in pharmaceutical chemicals, MgiPharma offers high-quality cyclopentolate hydrochloride for global export. They emphasize rigorous quality testing, stability, and consistent supply, positioning themselves as a reliable supplier in the ophthalmic API market.
Key Suppliers for Phenylephrine Hydrochloride
1. Sichuan Hisoar Medical Technology Co., Ltd.
A prominent Chinese manufacturer, Hisoar produces phenylephrine hydrochloride with a focus on sterile ophthalmic solutions. Their API manufacturing meets GMP standards, and they possess multiple international certifications. They also supply directly to pharmaceutical firms for formulation development.
2. KOPHARMA (Korea Pharm) Co., Ltd.
A South Korean pharmaceutical manufacturer with global distribution, KOPHARMA supplies phenylephrine hydrochloride with a reputation for high purity and consistency. Their manufacturing processes are certified under GMP and ISO standards, ensuring regulatory compliance.
3. Sakai Chemical Industry Co., Ltd.
Japanese-based, Sakai Chemical offers phenylephrine hydrochloride with high purity, supported by rigorous quality assurance protocols. Their supply chain benefits from Japan’s strong regulatory environment, making them a preferred choice for high-quality APIs.
4. Zhejiang Hisoar Medical Technology Co., Ltd.
An extension of Hisoar, Zhejiang Hisoar supplies phenylephrine hydrochloride in bulk, emphasizing GMP compliance and strict quality control, targeting global markets in the ophthalmic and nasal spray sectors.
Global Leadership and Regulatory Considerations
Manufacturers compliant with the US FDA, European EMA, and other international standards hold a competitive advantage. Suppliers with recent GMP inspections, valid certification, and a track record of regulatory compliance are preferred.
Additionally, the strategic importance of supply chain diversification has increased, especially considering geopolitical and pandemic-related disruptions. Leading pharmaceutical companies often engage multiple certified suppliers to mitigate risks.
Supply Chain and Quality Assurance
Ensuring API quality involves evaluating manufacturers’ quality systems, batch consistency, impurity profiles, and analytical testing capabilities. Most reputable suppliers provide detailed Certificates of Analysis (CoA), stability data, and compliance certificates.
Furthermore, some suppliers also offer contract manufacturing solutions, enabling end-to-end control over API sourcing and product development.
Emerging Suppliers and Market Trends
Emerging suppliers from India and Southeast Asia are gradually expanding their global footprint, backed by increasing investments in GMP-compliant manufacturing facilities. Notable mentions include companies like:
- Shandong Topscience Biotechnology Co., Ltd. (China)
- Spectrochem Pvt. Ltd. (India)
Traditional suppliers continue to innovate, improve yields, and expand their certifications to capture growing demand driven by expanding ophthalmic markets.
Conclusion
Reliable procurement of cyclopentolate hydrochloride and phenylephrine hydrochloride hinges on selecting suppliers with proven GMP compliance, strong regulatory standings, and supply chain robustness. Established Chinese companies such as Shaanxi Fuheng and Jiangsu Hengrui dominate the market, with notable contributions from South Korean and Japanese firms like KOPHARMA and Sakai Chemical.
Ongoing due diligence, including quality audits and supplier qualification, remains essential to ensure consistent product quality and regulatory adherence.
Key Takeaways
- Globally, China remains the dominant supplier of both APIs, emphasizing the importance of GMP compliance and regulatory approvals.
- Diversifying suppliers across geographies reduces supply chain risks amid geopolitical and pandemic disruptions.
- Quality assurance is critical; companies should verify certifications, analytical data, and audit reports before procurement.
- Up-and-coming Asian suppliers are increasing market share, driven by investments in GMP-level manufacturing.
- Long-term partnerships with suppliers offering robust quality systems and regulatory support ensure stability and compliance in API sourcing.
FAQs
Q1: Are Chinese suppliers of cyclopentolate hydrochloride and phenylephrine hydrochloride reliable for regulated markets?
Yes, many Chinese suppliers are GMP-certified and have obtained regulatory approvals in major markets such as the US and Europe, making them reliable sources when due diligence is performed.
Q2: How can I verify a supplier’s GMP compliance?
Request and review their Certificates of GMP certification, conduct audits or third-party inspections, and evaluate their regulatory approval history with agencies like FDA, EMA, or PMDA.
Q3: What are the challenges in sourcing these APIs globally?
Challenges include regulatory barriers, quality consistency, supply chain disruptions, and geopolitical issues. Maintaining multiple certified suppliers mitigates these risks.
Q4: Are there alternatives to Chinese suppliers for these APIs?
Yes. South Korea, Japan, and India are viable alternative sources, with companies like KOPHARMA, Sakai, and Spectrochem providing high-quality APIs.
Q5: What factors should companies consider when selecting a supplier for ophthalmic APIs?
Factors include GMP compliance, regulatory approvals, quality consistency, capacity, lead times, price, and after-sales support.
References
[1] U.S. Pharmacopeia (USP), "Cyclopentolate Hydrochloride," 2023.
[2] European Pharmacopoeia (EP), "Phenylephrine Hydrochloride," 2023.
[3] GlobalData, "Pharmaceutical Active Ingredients Market Report," 2022.
[4] company websites and regulatory filings of Shaanxi Fuheng, Jiangsu Hengrui, Sichuan Hisoar, KOPHARMA, Sakai Chemical, and others.
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